Some Anthrax lawsuit info: http://www.sskrplaw.com/vaccine/
ANTHRAX CHRONOLOGY
1500 B.C. God smote the Egyptians with
the ten plagues, the fifth of which,
dever, gives anthrax to livestock and
the sixth, shachean, to humans.
1600s Black Bane kills 60,000 cattle in
Europe, later called anthrax from
the
Greek for burning coal.
1876 German physician Robert Koch identifies
the bacterium bacillus
anthracis as the cause of anthrax, the
first microorganism linked directly
to
a disease.
1881 Louis Pasteur develops first vaccine
to immunize livestock from anthrax
using weakened bacterium.
1915 Norwegian police thwart first attempt
to use anthrax as a weapon when
they arrest a German agent carrying two
vials of the bacteria intended to
infect reindeer carrying supplies to allied
forces in Europe.
1937 Japanese immunologist Ishii Shiro
conducts experiments with anthrax on
Chinese prisoners in Harbin.
1942 England conducts experiments with
anthrax at Gruinard Island off the
coast of Scotland poisoning the soil.
1943 United States develops anthrax weapons.
1943 President Roosevelt appoints George
W. Merck, the president of Merck
Sharp and Dome, to lead the secret government
program to develop biological
weapons at Fort Detrick in Fredrick, Maryland.
1945 Anthrax outbreak kills one million
sheep in Iran
1950's George Wright develops original
cutaneous anthrax vaccine which is
first produced by Merck Sharp & Dohme.
1950s Government erects building 470 at
Fort Detrick, an eight story factory
for making anthrax.
1960 United States Army begins Operation
Whitecoat testing weopanized
anthrax and the anthrax vaccine on Seventh
Day Adventists.
1960 Dr. Phillip S. Brachman, Dr. Herman
Gold, Dr. Stanley Plotkin, Dr. F.
Robert Fekevy, Milton Werrin, and Dr.
Norman Ingraham conduct efficacy study
for cutaneous anthrax vaccine.
1962 In a report titled "Field Evaluation
of Human Anthrax Vaccine," Merck
researchers report the vaccine was still
highly effective for cutaneous
anthrax, though the case study focused
only on local and systematic
reactions
and not long term adverse effects.
1969 In a speech at Fort Detrick, Richard
Nixon orders the end of the United
States' offensive biological weapons program,
stating: "The human race
already carries in its hands too many
seeds of its own destruction.
1970 U.S. Food and Drug Administration
approves anthrax vaccine.
1970 The United States Public Health Service
issues the AVA license to the
state-owned facility operated by the Michigan
Department of Public Health
for protection against cutaneous anthrax
only.
1970-1990 Only a limited number of individuals
receive the AVA as reported
by Dr. Kwai Chan's General Accounting
Office Report to Congress.
1972 The United States, Soviet Union and
more than 100 other nations sign
the Biological and Toxin Weapons Convention
outlawing the development or
stockpiling of biological weapons.
1972 Government establishes United States
Army Medical Research Institute of
Infectious Diseases, based at Fort Detrick,
to develop and research defenses
to biological weapons.
1973 FDA publishes standards for making,
using and storing anthrax vaccine
at 21 CFR Section 620.20.
1978-80 More than 6,000 are infected and
as many as 100 killed by human
anthrax epidemic in Zimbabwe.
1979 Approximately 68 people die at a Soviet
Union military facility in
Sverdlovsk when weaponized aerosolized
anthrax is accidentally released.
Mid 1980's After the efficacy of the AVA
is demonstrated for cutaneous
anthrax, the FDA approves the AVA for
two limited markets: 1) individuals
who may come in contact with animal products
or high-risk persons such as
veterinarians and others handling potentially
infected animals; and 2)
individuals engaged in diagnostic or investigational
activities using
anthrax.
1982 Soviets build the Scientific Experimental
and Production Base in
Stepnogorsk to manufacture lethal strain
of anthrax.
1985 The Division of Biologic Standards,
now the Food and Drug
Administration, begins licensing vaccines.
1985 The DoD issues a Request for Proposal
soliciting the development of a
new anthrax vaccine. The Request for Proposal
states that there is no
vaccine in current use that would safely
and effectively protect military
personnel against exposure to anthrax.
1985 The FDA publishes a Proposed Rule
for a specific product review of the
AVA, stating that the vaccine's "efficacy
against inhalation anthrax is not
well documented."
1988 Iraq begins its biological weapons
program as its war with Iran winds
down ultimately producing 1000s of gallons
of anthrax.
1989 Assistant Secretary of Defense Robert
B. Barker writes in a letter to
Senator John Glenn that "current vaccines,
particularly the anthrax vaccine
do not readily lend themselves to use
in mass troop immunizations for a
variety of reasons.a higher than desirable
rate of reactogenicity and, in
some cases, lack of strong efficacy against
infection by the aerosol route
of exposure."
1990 On August 2, 1990, Iraq invades Kuwait.
1990 Army doctors Col. Takafuji and Col.
Phillip K. Russell describe the AVA
as a "limited use vaccine" and an "unlicensed
experimental vaccine" in an
article "Military Immunizations," in Infectious
Disease Clinics of North
America.
1990 The State of Michigan changes the
name of the original facility to the
Michigan Biologic Products Institute ("MBPI")
in order to make the move from
state owned and operated to private ownership.
1990 Despite the absence of any proof of
safety or efficacy of the AVA,
about 150,000 U.S. troops and personnel
receive at lease one dose of the AVA
during Operations Desert Shield and Desert
Storm, purportedly for the
purpose of protection against inhalation
anthrax if it were used as
biological weapons by Iraq.
1990 MBPI changes both the fermenters and
the filters used in manufacturing
the AVA without notifying the FDA causing
a hundred fold increase in the
protective antigen levels in vaccine lots.
1990-93 Anthrax is released in Tokyo by
the terrorist group Aum Shinrikyo.
1991 Despite the absence of any proof of
safety or efficacy of the AVA,
about 150,000 of 500,000 U.S. troops and
personnel receive at lease one dose
of the AVA during Operations Desert Shield
and Desert Storm, purportedly for
the purpose of protection against inhalation
anthrax if it were used as
biological weapons by Iraq.
1991 On February 28, 1991, Iraq surrenders;
as condition of surrender,
UNSCOM inspect Iraqi facilities confirming
huge stockpile of weaponized
anthrax.
1991 MBPI and the U.S. Army enter into
an agreement for the manufacture of
the AVA.
1991 In preparation for the Gulf War, U.S.
troops receive anthrax vaccine;
hundreds later complain of a variety of
autoimmune problems given the name
"Gulf War Syndrome" and believed by many
to be adverse reactions from the
vaccine.
1991-2000 Hundreds of Gulf War Veterans
complain of a variety of autoimmune
problems given the name AGulf War Syndrome@
and believed by many to be
adverse reactions to the vaccine.
1991 The U.S. Army, an agency of the DoD,
awards MBPI the Commander's Award
for Public Service for their supply of
the AVA during the Gulf War.
1993 In June 1993, Pentagon creates joint
program office for biological
defense.
1993 MBPI fails an FDA inspection of its
facilities.
1993 The Pentagon's deliberative process
of mass vaccination of military
personnel with the AVA begins with the
development and implementation of
DoD's Directive 6205.3, DoD Immunization
Program for Biological Warfare
Defense.
1993 Ronda Wilson joins the U.S. Army.
1993 AUM Shinrikyo members fail in their
attempt to spray anthrax from
aerosol device on roof in downtown Tokyo;
2 years later, they release saran
gas in Tokyo subway killing 12.
1994 On November 26, 1994, William Perry
Deputy Secretary of Defense signs
order committing to program ordering troops
to be given AVA.
1994 Senate report reveals the sale of
Anthrax to Irag during its war with
Iran with approval by the U.S. Department
of Commerce.
1994 Senate Report 103-97 calls the AVA
"investigational."
1995 The FDA issues a warning letter to
MBPI requiring it to remedy the
violations at its facility.
1995 The Department of the Army contracts
with the Science Applications
International Corporation ("SAIC") to
develop a plan to obtain FDA approval
for a license amendment for the AVA in
order to add inhalation anthrax
exposure to the product license and to
enable BioPort to list on the product
license that the AVA was effective against
inhalation anthrax.
1995 The Army Joint Program Office for
Biological Defense notes there was
insufficient data to demonstrate protection
against inhalation anthrax.
1995 Sandra Larson joins the U.S. Army.
1996 The DoD seeks and receives permission
from the FDA to begin
vaccinations of all military personnel
without obtaining a new licensed
indication for the AVA.
1996 As part of the Army/SAIC plan, MBPI
submits an IND application in order
to modify the product's license to add
an indication for inhalation anthrax.
1997 MBPI executes another U.S. Army contract
in order to maintain the AVA
stockpile.
1997 The FDA sends MBPI a Notice of Intention
to Revoke because no real
changes had been made to the facility.
1997 MBPI fails another FDA inspection.
1997 Secretary of Defense William Cohen
announces the Anthrax Vaccination
Immunization Program (AVIP) for all U.S.
military personnel.
1997 Internal FDA memo describes use of
DoD's use of the AVA as experimental
requiring informed consent.
1997-2003 All military personnel, including
new recruits, begin receiving
the six-shot series of the anthrax vaccination
in the following inoculation
program: 1) Phase 1: Forces assigned now
or rotating to high threat areas in
Southwest Asia and Korea; 2) Phase 2:
Early deploying forces into high
threat areas; 3) Phase 3: Remainder of
the force and new recruits; and 4)
Phase 4: To Continue the Program, annual
booster shots.
1998 Anthrax vaccination plan for all military
service members is approved
by U.S. Secretary of Defense William Cohen.
1998 The FDA issues a report finding that
the manufacturing process for
Anthrax was not validated and listed 11
pages of quality control failures
for anthrax vaccine production, including
reuse of expired vaccine, grossly
inadequate testing and use of lots that
failed testing.
1998 An FDA Inspection report dated February
28th reports that Lot Number
FAVO44, filled on January 7th had an "invalid"
potency test on December 8,
1997. Also, Lot No. FAVO31 was partially
formulated from sublots
contaminated with microorganisms.
1998 Army Secretary Togo West, Jr. takes
steps to approve a request to
indemnify BioPort against all liability
arising from "the unusually
hazardous risks associated with potentially
severe adverse reactions and the
potential lack of efficacy of the AVA."
The indemnification concerns,
according to Secretary West, were a result
of the limited use of the vaccine
on too small a scale to permit accurate
assessments of types and severities
of adverse reactions and, insufficient
experience in mass immunization
programs to evaluate the efficacy of the
vaccine.
1998 BioPort jointly purchases the state
owned MBPI with former MBPI lab
directors for approximately $24 million.
1998 FDA suspends AVA shipments from BioPort
because of questions about the
facility's quality control.
1998 Sandra Larson leaves for a year tour
of duty at Camp Stanley, South
Korea. Sandra Larson receives her first
of six AVA injections in the
18-month anthrax series on September 16.
The Lot Number for this first AVA
injection is FAVO17. On September 30,
October 13 and April 6, 1999 Sandra
Larson receives her next three AVA injections
from Lot Number FAVO17.
1998 Ronda Wilson receives her first AVA
injection from Lot Number FAVO36.
1999 Ronda Wilson receives her second AVA
injection and immediately
thereafter she experiences numerous other
symptoms including: unrelenting
nausea, stomach pain and seizure-like
spasms.
1999 After Ronda Wilson receives her third
AVA injection with Lot Number 041
she has significant memory loss and her
bowel, small intestine, colon and
heart are all damaged.
1999 Sandra Larson receives her fifth AVA
injection from Lot Number FAVO 44.
1999 Sandra Larson is relieved of her duties
in South Korea and her new
orders require her to relocate to Fort
Rile, Kansas.
1999 BioPort is still unable to ship the
AVA and at BioPort's request the
DoD restructures BioPort's contract, providing
BioPort with $24.1 million
dollars in relief, reducing the number
of doses demanded to 4.6 million and
agreed to raise the price per dose to
$10.64.
1999 Dr. Kathryn Zoon writes to Dr. Sue
Bailey, Assistant Secretary of
Defense Health Affairs, reiterating her
position that the AVIP follow the
FDA approved schedule.
1999 BioPort's manufacturing plant is found
to have about 30 deficiencies in
safety, sterility and consistency.
2000 Office of the Inspector General, DoD,
issues an audit report
D-2000-105, reporting that over $2 million
in taxpayer funds advanced to
BioPort were not spent on improvements
to vaccine production but spent on
office remodeling, furniture for the CEO,
parking lot re-paving, unwarranted
travel expenses, unsubstantiated consulting
costs, and an unrelated medical
program. Additionally, senior managers
planned on rewarding themselves $1.2
million in bonuses and a retired employee
is collecting $10,000/month in
severance and consulting fees.
2000 The Full Committee on Government Reform
adopts the Subcommittee report
recommending suspension of the AVIP.
2000 425,976 service members receive 1,620,793
doses of AVA.
2000 The DoD curtails the anthrax program
because of vaccine shortages at
Bioport forcing some soldiers to actually
suspend vaccination mid-process.
Still, BioPort is awarded a new contract
which provides for $2-$2.5 million
per month to cover costs related to getting
the company to pass FDA approval
of renovated anthrax production facilities.
2000 BioPort voluntarily recalls the AVA
because wrong expiration dates were
put on the labels; at the same time, BioPort's
scientists seek royalties for
their part in changing the anthrax vaccination
process.
2000 Sandra Larson receives her sixth and
final injection of the AVA from
Lot Number FAVO 31 on March 12 2000. Sandra
Larson's blood capillaries are
bursting and she is experiencing heavy
vaginal bleeding. On April 8th she is
admitted to the hospital and on April
10th Sandra Larson is put into the
intensive care unit at Kansas Medical
Center and is diagnosed with aplastic
anemia, where her bone marrow had stopped
producing blood cells.
2000 On May 2nd, Sandra Larson is supposed
to be transferred to Ft. Lewis in
order to be treated at Madigan Army Medical
Center; however the plane that
is transferring her has to make an emergency
landing at Travis Air Force
Base in California.
2000 On June 12th, breathing through a
ventilator, Sandra Larson goes into a
coma. On June 14th, as result of the inoculation
of the AVA, Sandra Larson
dies.
2000 Richard Dunn, a BioPort employee required
to take the AVA as a
condition of his employment, dies from
an adverse reaction to the vaccine.
2001 Ronda Wilson is discharged from the
U.S. Army.
2001 In the weeks after the September 11
terrorist attacks on the Pentagon
and World Trade Center, letters containing
anthrax spores are mailed to
American Media in Miami, NBC, ABC, the
New York Times, the New York Post and
Governor Pataki's office in New York City,
and to Senator Daschle's office
in Washington D.C. One man dies after
inhaling anthrax at the offices of
American Media, three postal workers die
in Washington D.C., and more than a
dozen others are infected with cutaneous
anthrax. Some call for the anthrax
vaccine to be available for postal workers
and the general public. |